Z-0380-2022 Class II Terminated

Recalled by Ossur Americas — Foothill Ranch, CA

Recall Details

Product Type
Devices
Report Date
December 22, 2021
Initiation Date
November 9, 2021
Termination Date
December 18, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

Reason for Recall

Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.

Distribution Pattern

US Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY, NJ, PA, OH, DC, MD, VA, NC, SC, GA, MS, LA, TN, TX, KY, IN, AZ, MI, WI, MN, IL, IA, MO, NE, MT, ID, CO, NM, WA, OR, NV, UT, KS, AK, VT, AR, OK, AL, SD, WV, PR.

Code Information

Instructions for Use Rev. 3 2018